Clinical trials: Diagnostic Accuracy
Skin Lesions, Melanocytic Nevi
Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions.
- Conditions
- Skin Lesions, Melanocytic Nevi, Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin
- Trial name
- LegitHealth PH (NCT07428941)
- Testing
- AI-based medical device for aided diagnosis in dermatological conditions
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- AI Labs Group S.L
Alzheimer Disease
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
- Trial name
- NCT03901092
- Testing
- flortaucipir F 18
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Avid Radiopharmaceuticals
Dermatitis, Melanoma (Skin Cancer)
Using Artificial Intelligence to Help Doctors Identify Different Skin Conditions and Improve Patient Care
This study aims to determine if an artificial intelligence (AI) medical device can help doctors more accurately identify a wide variety of skin conditions and improve the efficiency of patient consultations.
- Conditions
- Dermatitis, Melanoma (Skin Cancer), Alopecia, Urticaria
- Trial name
- LegitHealthSAN (NCT07428954)
- Testing
- AI-based medical device for aided diagnosis in Dermatology
- Where
- Spain
- Volunteers
- 16 people
- Sponsor
- AI Labs Group S.L
Normal Pressure Hydrocephalus
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing…
- Trial name
- NCT00793416
- Testing
- Shunt flow detection
- Where
- United States
- Sponsor
- NeuroDx Development
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology…
- Trial name
- ADAPT-ENRICH (NCT02540083)
- Testing
- DBT and FFDM
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- GE Healthcare
Endometriosis, Diagnosis
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery.
- Trial name
- NCT05698212
- Testing
- MetriDx
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Hera Biotech, Inc.
Cardiovascular Diseases, Cancer
Phase I Human Analytics (HALO) Study
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders.
- Conditions
- Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Trial name
- HALO (NCT05423860)
- Testing
- no interventions will be performed (observational)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- HALO Diagnostics
Coronary Artery Disease
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
- Trial name
- EDAM-CAD (NCT05825911)
- Testing
- Rest/Stress MCG scan, Rest MCG scan
- Where
- 2 sites in South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- AMCG
Sepsis, Infection
The Performance of the Mologic Biomarker Panel in Infection
This study is a prospective, single center, observational, cohort study of patients to determine whether the Mologic Biomarker Panel can identify patients with infection from those without, including those with other reasons for…
- Trial name
- NCT03217552
- Testing
- Mologic Biomarker Panel
- Where
- United Kingdom
- Volunteers
- 600 people
- Sponsor
- Mologic Ltd
Acute Coronary Syndrome
VitalScan MCG Rule-out Multi-centre Pivotal Study - US
A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the…
- Trial name
- MAGNET ACS (NCT03546933)
- Testing
- VitalScan Magnetocardiograph
- Where
- 5 sites in United States
- Volunteers
- 651 people
- Sponsor
- Creavo Medical Technologies Ltd
Acute Coronary Syndrome
VitalScan MCG Rule-out Multi-centre Pivotal Study - UK
The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain…
- Trial name
- MAGNET-ACS (NCT02921438)
- Testing
- VitalScan Magnetocardiograph
- Where
- 5 sites in United Kingdom
- Volunteers
- 756 people
- Sponsor
- Creavo Medical Technologies Ltd
PJI
Infection Consortium Study#1
In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.
- Trial name
- NCT06153446
- Testing
- Synovasure® Comprehensive Infection Panel
- Where
- United States
- Volunteers
- 810 people
- Sponsor
- Zimmer Biomet
Allergy, Hypersensitivity, Immediate
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices…
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Trial name
- NCT07400718
- Testing
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- QHSLab, Inc.
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease
This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG).
- Trial name
- HF-CAD (NCT06880120)
- Testing
- Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing
- Where
- Uzbekistan
- Volunteers
- 1,534 people, healthy volunteers welcome
- Sponsor
- Heart Force Medical Inc.
Birch Pollen Allergy, Grass Pollen Allergy
Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in…
- Conditions
- Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy, Cat Allergy
- Trial name
- MADMAX (NCT04435678)
- Testing
- ALEX² test using the MAX 45k automated laboratory system
- Where
- 2 sites in Austria
- Volunteers
- 839 people
- Sponsor
- MacroArray Diagnostics GmbH
Heart Murmurs, Wheezing
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app.
- Trial name
- KCI-1 (NCT07044128)
- Testing
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Where
- Peru
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Lapsi Health Holding B.V.
Acute Kidney Injury, Stage 2 Acute Kidney Injury
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test
- Conditions
- Acute Kidney Injury, Stage 2 Acute Kidney Injury, Stage 3 Acute Kidney Injury
- Trial name
- NCT06036758
- Testing
- VIDAS® NEPHROCLEAR™ CCL14 Test
- Where
- 2 sites in United States
- Volunteers
- 477 people
- Sponsor
- BioMérieux
Asthma, COPD
Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis
Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry.
- Trial name
- Care4All (NCT07245576)
- Where
- 12 sites in Argentina, Egypt and 5 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Cow's Milk Allergy
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms…
- Trial name
- APTITUDE (NCT04492683)
- Testing
- DBV1605
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- DBV Technologies